First participant enrolled in Gritstone second generation COVID-19 vaccine study

The COVID-19 vaccines authorized to date use the spike protein on the SARS-CoV-2 virus to teach the immune system to recognize key parts of the virus and generate strong B-cell and T-cell immune responses. An early phase clinical trial is being conducted through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC) to assess the safety and tolerability of different doses of two-part investigational COVID-19 vaccine regimens that include bits of other SARS-CoV-2 proteins in addition to the spike. The study is being conducted in collaboration with Gritstone Oncology, Inc., a clinical-stage biotechnology company which develops next generation cancer and infectious disease immunotherapies, and IDCRC sites at Saint Louis University Vaccine & Treatment Evaluation Unit (VTEU), Emory University VTEU - The Hope Clinic, and University of Washington VTEU.

“Gritstone’s vaccine may provide more comprehensive viral protection by inducing a better combination of T cell responses and neutralizing antibodies as compared to the currently available vaccines,” said Daniel Hoft, MD, PhD, director of Saint Louis University’s Center for Vaccine Development and Division of Infectious Diseases, Allergy and Immunology, National Vaccine Advisory Committee member, and protocol chair and lead principal investigator of Gritstone’s COVID study. “It is important that we move forward with developing these next generation vaccines because we do not yet know whether the existing vaccines that have been granted emergency use authorization will provide long-term immunity or prevent transmission. Improved vaccines that can accomplish these additional benefits may be needed to continue mitigating the ongoing pandemic.”

The trial will examine the immune responses generated by these regimens in healthy adults ages 18 years and older, including some adults older than age 60. The vaccine components consist of a harmless, non-replicating chimpanzee adenovirus vector (ChAd) and self-amplifying mRNA (SAM), both of which contain instructions for making specific SARS-CoV-2 proteins. Visit ClinicalTrials.gov and search identifier NCT04776317 for additional details.

About Infectious Disease Clinical Research Consortium (IDCRC)
The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. View other IDCRC studies

About Gritstone Oncology
Gritstone Oncology (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of immunotherapies against multiple cancer types and infectious diseases. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE^TM, which is designed to predict antigens that are presented on the surface of cells, such as tumor or virally-infected cells, that can be seen by the immune system; and second, the ability to develop and manufacture potent immunotherapies utilizing these antigens to potentially drive the patient’s immune system to specifically attack and destroy disease-causing cells. The company’s lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an “off the shelf” shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies. The company also has a bispecific antibody (BiSAb) program for solid tumors in lead optimization. Within its infectious disease pipeline, Gritstone is advancing CORAL, a COVID-19 program to develop a second-generation vaccine with support from departments within the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation and a license agreement with La Jolla Institute for Immunology.